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BioWorld - Friday, April 17, 2026
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Home » FDA authorizes home sample kit for Everlywell, shuts down similar effort in Seattle
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FDA authorizes home sample kit for Everlywell, shuts down similar effort in Seattle

May 18, 2020
By Mark McCarty
The FDA has granted an emergency use authorization (EUA) for the home sample collection kit made by Austin, Texas-based Everlywell Inc., which can be run on two lab-developed tests. However, the agency has also shut down a Gates Foundation-backed effort in Seattle to develop another home sample collection kit even though the organization behind the effort has been authorized by state health authorities. The FDA announced the news about the Everlywell EUA with the stipulation that the user of the kit has completed an online questionnaire that is subsequently reviewed by a health care professional.
Medical technology Regulatory Diagnostics Coronavirus FDA

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